Itch And Pain Relief Cream
FDA Label NDC 73492-802

6 label sections · Submitted to the FDA by Alaina Healthcare Private Limited · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alaina Healthcare Private Limited for the product Itch And Pain Relief (NDC 73492-802). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient                                                               Purpose

Diphenhydramine Hydrochloride 2%.........................Topical Analgesic

Zinc Acetate 0.1%.......................................................Skin Protectant

Uses

  • temporarily relieves pain and itching associated with:
    • ​​​​​​​​​​​insect bites
    • minor burns
    • minor skin irritation
    • ​​​​​​​​​​​​rashes due to poison ivy, poison oak, and poison sumac
    • dries the weeping and oozing of poison ivy, oak and sumac

Warnings

For external use only

Directions

  • Do not use more than directed
  • Adults and children 2 years of age and older: ​​​​​​​apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age: ask a doctor

Other Information

  • store at controlled room temperature 20°-25°C (68°-77°F)
  • close cap tightly after use

Inactive Ingredients

Benzyl Alcohol, Ceteareth 20, Cetearyl Alcohol, Citric Acid, Propylene Glycol, Water.

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